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12:00 AM
 | 
Aug 24, 2009
 |  BioCentury  |  Product Development

Speed Bump for Arzerra

A 2007 protocol amendment that was designed in part to speed enrollment in a Phase III trial of Arzerra ofatumumab in patients with Rituxan-refractory follicular non-Hodgkin's lymphoma has come back to bite Genmab A/S. The change could be one reason why the study reported last week didn't show sufficient efficacy to enable Genmab and partner GlaxoSmithKline plc to file for accelerated approval in the indication.

Genmab had hoped it could run a smaller trial of Arzerra at a high dose in very sick patients with Rituxan-refractory NHL and still demonstrate enough efficacy to file for accelerated approval.

The companies have filed in the U.S. and EU for approval of Arzerra for chronic lymphocytic leukemia (CLL); the U.S. PDUFA date is Oct. 31. But they will have to run a new, larger Phase III study in NHL for a chance to submit applications to market the anti-CD20 human mAb in the much larger market in that indication.

In addition, Genmab won't get a DKK450 million ($85.2 million) milestone payment it had expected from GSK. Consequently, the biotech lowered its guidance for 2009 revenues to DKK750 million ($142 million) from DKK1.2 billion.

The primary endpoint in the NHL study reported last week was overall response rate (ORR) at six months after the last infusion in the 1,000 mg cohort.

"We were aiming at a response rate above 20% in this refractory patient population. A response rate of 20% and above is clinically meaningful, in particular due to the low toxicity of the treatment," CSO and President of R&D Jan van de Winkel told BioCentury.

The actual response rate was 10%.

The open-label study enrolled 116 patients who were refractory to either Rituxan rituximab monotherapy or Rituxan in combination with chemotherapy. All patients first received a 300 mg infusion of Arzerra followed...

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